CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan

Part of paid clinical trials in La Jolla, California.

Sponsor
Adnexus, A Bristol-Myers Squibb R&D Company
Study ID
NCT00562419
Phase
PHASE2
Status
Unknown

Conditions

  • Brain and Central Nervous System Tumors
  • Recurrent Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells. PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.

Key Dates

Start date
Oct 31, 2007
Status verified
Oct 2010
Primary completion
Jun 30, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    CT-322
  • Experimental: 2
    CT-322 and irinotecan hydrochloride

Primary Outcome Measure

Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1) [ Time Frame: 15 ± 5 days post the last dose of study drug ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037-0845-
University of KentuckyLexingtonKentucky40536-
Dana Farber Cancer InstituteBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Duke University Medical CenterDurhamNorth Carolina27710-
Rhode Island HospitalProvidenceRhode Island02903-
MD Anderson Cancer CenterHoustonTexas77030-
University of VirginaCharlottesvilleVirginia22908-
University of Wisconsin HospitalMadisonWisconsin53792-

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